MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP Z O.O CITADEL PATIENT CARE SYSTEM; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number CX811A3F3AMAB0

Device Problem Insufficient Information (3190)

Patient Problem Laceration(s) (1946)

Event Date 06/12/2019

Event Type  Injury  

Event Description

On (b)(6) 2019 arjo was informed about the event, which occurred in the kindred hospital in the us.Based on the information reported, the patient was injured while being transfer from the wheelchair to the arjo citadel bed.The patient sustained laceration on the left leg, which required sutures.

• Brand Name: CITADEL PATIENT CARE SYSTEM
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP Z O.O; ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• MDR Report Key: 8774640
• MDR Text Key: 150527169
• Report Number: 1419652-2019-00183
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: CX811A3F3AMAB0
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/10/2019
• Distributor Facility Aware Date: 06/13/2019
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention